An Active Surveillance Program for Cases of Medullary Thyroid Carcinoma (MTC)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Novo Nordisk A/S
AstraZeneca
Information provided by (Responsible Party):
United BioSource Corporation
ClinicalTrials.gov Identifier:
NCT01511393
First received: November 30, 2011
Last updated: September 2, 2014
Last verified: September 2014
  Purpose

This study is conducted in the United States of America (USA). The aim of the study is to monitor the number of annual new cases of medullary thyroid carcinoma (MTC) and to establish a registry for these new cases in order to identify any possible increase related to the introduction of liraglutide, exenatide once-weekly, and other GLP-1 receptor agonists into the US market.


Condition Intervention
Diabetes
Diabetes Mellitus, Type 2
Medullary Thyroid Carcinoma
Other: No treatment given

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Medullary Thyroid Carcinoma Surveillance Study: A Case-Series Registry

Resource links provided by NLM:


Further study details as provided by United BioSource Corporation:

Primary Outcome Measures:
  • Annual incidence of MTC in the US to identify any possible increase related to the introduction of liraglutide, exenatide once-weekly, and other GLP-1 receptor agonists into the US market [ Time Frame: January 2012 to December 2027 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Family history of cancer (including history of MEN2A or MEN 2B, history of FMTC, history of RET proto-oncogene mutations), Patient demographic characteristics, Patient prior history of thyroid diseases [ Time Frame: January 2012 to December 2027 ] [ Designated as safety issue: No ]
  • Dose and duration of use of all previous diabetes medication exposures (including liraglutide, exenatide once-weekly, other GLP-1 agonists, DPP4 inhibitors, and insulin) [ Time Frame: January 2012 to December 2027 ] [ Designated as safety issue: No ]
  • Lifestyle factors such as smoking and alcohol use [ Time Frame: January 2012 to December 2027 ] [ Designated as safety issue: No ]
  • Environmental exposures (occupational history, radioiodine exposure, nuclear fallout) [ Time Frame: January 2012 to December 2027 ] [ Designated as safety issue: No ]

Estimated Enrollment: 6750
Study Start Date: January 2012
Estimated Study Completion Date: December 2027
Estimated Primary Completion Date: December 2027 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Questionnaire Other: No treatment given
Completion of a questionnaire

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

People with medullary thyroid carcinoma invited by either written invitation from the participating cancer registry or the diagnosing physician to participate in the study.

Criteria

Inclusion Criteria:

  • A record of medullary thyroid carcinoma (MTC) identified from state/regional population-based cancer registries
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01511393

Locations
United States, West Virginia
United BioSource Corporation
Morgantown, West Virginia, United States, 26505-8065
Sponsors and Collaborators
United BioSource Corporation
Novo Nordisk A/S
AstraZeneca
Investigators
Study Director: Annette Stemhagen, DrPH, FISPE United BioSource Corporation
  More Information

Additional Information:
No publications provided

Responsible Party: United BioSource Corporation
ClinicalTrials.gov Identifier: NCT01511393     History of Changes
Other Study ID Numbers: NN2211-3965, U1111-1125-4362
Study First Received: November 30, 2011
Last Updated: September 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by United BioSource Corporation:
GLP1
Glucagon like peptide
liraglutide
exenatide once weekly

Additional relevant MeSH terms:
Diabetes Mellitus
Thyroid Diseases
Diabetes Mellitus, Type 2
Thyroid Neoplasms
Carcinoma
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 22, 2014